BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 5012623 · Received August 18, 2015

    Report

    Report Number
    2938836-2015-28461
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    June 21, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PARTIAL LEAD WITH THE CONNECTOR PINS MEASURING 11.5CM WAS RETURNED IN THREE SEGMENTS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS HYPERTENSIVE AND ARTERIOSCLEROSIS CARDIOVASCULAR DISEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544463 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1580/65 0002127160

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death